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A study to compare the effect of nasal spray forms of ketamine and dexmedetomidine in reducing pain after nose surgery (septoplasty) in adult patients

Comparison of Intranasal Dexmedetomidine and Intranasal Ketamine as preemptive analgesics in patients undergoing septoplasty: A prospective randomized trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092743
Enrollment
60
Registered
2025-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J342- Deviated nasal septum

Interventions

Intervention1: Intranasal Dexmedetomidine : Intranasal dexmedetomidine 2 mcg/kg administered using an insulin syringe 45 60 minutes prior to induction. The drug is instilled in 0.3 ml increments, half

Sponsors

Dr Abin Thomas
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 60 years, ASA physical status I or II, undergoing elective septoplasty under general anaesthesia at AIIMS Mangalagiri, willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients aged less than 18 or more than 60 years of age, known allergy to study drugs, pregnant or lactating women, BMI more than 30 kg perm , septoplasty lasting more than 120 minutes, refusal to participate.

Design outcomes

Primary

MeasureTime frame
Numeric Rating Scale (NRS) pain score at the 4th postoperative hourTimepoint: primary outcome NRS pain score will be assessed at the 4th postoperative hour. So, the time point for the primary outcome is the 4th hour after surgery

Secondary

MeasureTime frame
Requirement of additional intraoperative analgesics Timepoint: Throughout intraoperative period ;Requirement of rescue analgesics in postoperative period Timepoint: Within 24 hours postoperatively;Incidence of drug-related adverse effectsTimepoint: From drug administration until 24 hours postoperatively ;Sedation score using Ramsay Sedation ScaleTimepoint: Preoperatively and at 1, 4, 12, and 24 hours postoperatively ;Intraoperative and postoperative hemodynamic parameters (heart rate, blood pressure, MAP, SpO2)Timepoint: Intraoperatively every 15 minutes and postoperatively at 1, 4, 12, and 24 hours

Countries

India

Contacts

Public ContactDr Abin Thomas

Department of Anesthesiology,AIIMS Mangalagiri

drsunit.anesth@aiimsmangaklagiri.edu.in9878984295

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026